JP7640690B2 - Drug Delivery Device Cassette - Google Patents

Description

The present disclosure relates to a drug delivery device having a cassette. The cassette may include an extendable needle assembly.

Conventional injection devices are often used to drive a needle through a surface, for example, injecting a drug, withdrawing fluids from a closed container such as a vial, taking samples in chemical instrumentation, etc. Considering the example of injecting a drug into a patient, it may be beneficial to administer the drug without the presence of a medical professional (e.g., when taken frequently). The use of standard glass cartridges can be a challenge in developing a space-efficient injection device. Furthermore, disposal of glass cartridges can incur more environmental costs compared to other materials. Furthermore, it can be difficult to ensure that the injection device is properly assembled and oriented by the user before use.

The present disclosure provides a device and method for delivering a medication comprising a cassette having a cartridge configured to hold a quantity of medication and an extendable and retractable needle assembly.

According to an exemplary embodiment of the present disclosure, a drug delivery device includes a cassette including a cartridge configured to hold a quantity of medication, a stopper drive system configured to drive the medication from the cartridge, the stopper drive system including a stopper, the stopper moving less than 10 mm to deliver a 1 mL quantity of medication, and a needle assembly directly coupled to the cartridge and movable between an extended configuration and a retracted configuration, the needle assembly having an actuation gear movable between a first position and a second position, in the extended configuration, the actuation gear is in the second position, and the needle assembly provides fluid communication between the cartridge and the needle assembly, and in the retracted configuration, the actuation gear is in the first position, and no fluid communication is provided between the cartridge and the needle assembly.

According to another embodiment of the present disclosure, a method of delivering a medicament to a patient includes coupling a housing of a drug delivery device to a cassette, orienting the housing relative to the cassette, placing the drug delivery device against the skin of the patient, actuating a needle assembly of the drug delivery device to extend a first needle into the skin of the patient and extend a second needle into a septum of a polymer cartridge containing a quantity of the medicament, actuating a drive system to drive the medicament from the polymer cartridge through the needle assembly to the patient, and retracting the first and second needles within the needle assembly.

According to another embodiment of the present disclosure, a drug delivery device includes a reusable housing, a cassette coupled to the reusable housing, the cassette having a height-to-diameter ratio of 2:1 to 1:1, a cartridge supported by the cassette and configured to hold a quantity of medication, and an orientation mechanism configured to orient the cassette relative to the reusable housing.

According to another embodiment, a drug delivery device is disclosed having a cassette for coupling to a reusable module. The cassette includes a cartridge configured to hold a quantity of medicament. The cartridge extends between a proximal end and a distal end along a centrally located axis. A stopper drive system is configured to drive the medicament from the cartridge. The stopper drive system includes a stopper and an interface end coupled to the stopper and configured to be driven by a first motor or actuator of the reusable module to move the stopper. A needle assembly is directly coupled to the cartridge and movable between an extended configuration and a retracted configuration. The needle assembly has an actuation gear movable between a first position and a second position. The actuation gear is configured to be driven directly or indirectly by a second motor or actuator of the reusable module. In the extended configuration, the actuation gear is in a second position and the needle assembly provides fluid communication between the cartridge and the needle assembly. In the retracted configuration, the actuation gear is in a first position and no fluid communication is provided between the cartridge and the needle assembly. The interface end extends from the top end of the cartridge and is coaxial with the shaft, and the actuation gear is positioned to be externally engaged by a second motor or actuator of the reusable module at a location offset from the shaft.

The above and other features and advantages of the present disclosure, as well as the manner in which they are realized, will become more apparent, and the invention itself will be better understood, by reference to the following description of an embodiment of the invention in conjunction with the accompanying drawings.

FIG. 1 is a simplified cross-sectional view of an exemplary drug delivery device. FIG. 13 is a simplified cross-sectional view of another exemplary drug device with a removable cassette and needle assembly. FIG. 13 is a simplified cross-sectional view of yet another exemplary drug delivery device comprising a removable needle assembly. FIG. 1 is a perspective view of yet another exemplary drug delivery device. FIG. 5 is a cross-sectional view of the device of FIG. FIG. 1 is a perspective view of yet another exemplary drug delivery device. FIG. 7 is a cross-sectional view of the device of FIG. 6. FIG. 5 is a perspective view of the drug delivery device of FIG. 4. FIG. 9 is a schematic diagram of the drive system of FIG. 8 . FIG. 9 is a schematic diagram of a control system for the drive system of FIG. 8 . FIG. 1 is a perspective view of an exemplary needle assembly. FIG. 12 is a rear view of the needle assembly of FIG. FIG. 12 is an exploded view of the needle assembly of FIG. FIG. 12 is a cross-sectional view of the needle assembly of FIG. FIG. 12 is a perspective view of a needle mechanism within the needle assembly of FIG. FIG. 12 is a perspective view of a needle mechanism within the needle assembly of FIG. FIG. 17 is a side view of the needle mechanism of FIGS. 15 and 16 excluding the drive member. FIG. 17 is a side view of the needle mechanism of FIGS. 15 and 16 excluding the drive member. FIG. 17 is a perspective view of the drive member of the needle mechanism of FIGS. 15 and 16 . FIG. 17 is a perspective view of the drive member of the needle mechanism of FIGS. 15 and 16 . 23 is a side view of the needle mechanism of FIGS. 15 and 16 illustrating movement of the needle mechanism from the first configuration of FIG. 21 to the second configuration of FIG. 22 . FIG. 23 is a side view of the needle mechanism of FIGS. 15 and 16 illustrating movement of the needle mechanism from the first configuration of FIG. 21 to the second configuration of FIG. 22 . FIG. FIG. 13 is a perspective view of yet another embodiment of a needle assembly. FIG. 24 is an exploded view of the needle assembly of FIG. FIG. 24 is a perspective view of a needle mechanism within the needle assembly of FIG. 23 . FIG. 26 is a perspective view of a needle support of the needle mechanism of FIG. 25 . FIG. 26 is a perspective view of a drive member of the needle mechanism of FIG. 38A is a side view of the needle mechanism in the needle assembly of FIG. 23 , illustrating movement of the needle mechanism from the first configuration of FIG. 38 . FIG. 5 is a perspective view of a needle mechanism in the device of FIG. FIG. 5 is a perspective view of a needle mechanism in the device of FIG. FIG. 5 is a perspective view of another needle mechanism within the device of FIG. 4 . FIG. 5 is a perspective view of another needle mechanism within the device of FIG. 4 . FIG. 6 is a perspective view of a needle mechanism in the device of FIG. 5 . FIG. 6 is a perspective view of a needle mechanism in the device of FIG. 5 . FIG. 1 is a schematic diagram of an exemplary wireless communication system for use with a drug delivery device.

Corresponding reference characters indicate corresponding parts throughout the several views. The illustrations described herein illustrate exemplary embodiments of the present invention, and such illustrations should not be construed as limiting the scope of the present invention in any manner.

Exemplary drug delivery devices 11, 12, and 13 are shown in FIGS. 1-4 and 6. Each of the illustrated devices 11, 12, and 13 is a reusable pen-type drug injection device that can be manually handled by a user (e.g., a patient, a caregiver, or a medical professional) to deliver medication to a patient. The cassettes 100, 200 may also be referred to as drug delivery devices or drug delivery cassettes. The combination of the cassettes 100, 200 and the motor housing system (which may be reusable) may also be considered a drug delivery device. In certain embodiments, a user may selectively set a dose and then inject the set dose into a patient. The devices 11, 12, 13, 100, and 200 are intended to be exemplary and not limiting, as the needle assemblies described further below may be used in other differently configured devices.

The drug may be of any type that can be delivered by such devices 11, 12, 13, 100, and 200. The drug may be in a fluid form of various viscosities or any other suitable form. Drugs may include, but are not limited to, insulin, insulin analogs such as insulin lispro or insulin glargine, insulin derivatives, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide (GIP), GIP analogs, GIP derivatives, e.g., GIP/GLP-1 receptor agonists, dual agents in any combination of the above such as tirzepatide, retatortide, oxyntomodulin analogs, oxyntomodulin derivatives, and the like. The therapeutic agents include, but are not limited to, one or more therapeutic agents including an IL-23 antibody analog or derivative such as mirikizumab, an IL-17 antibody analog or derivative such as ixekizumab, a therapeutic agent for pain-related treatment such as galcanezumab or lasmiditan, an antibody analog or derivative for atopic dermatitis-related treatment such as leplikizumab, an antibody analog or derivative related to the treatment of neurodegeneration such as donanemab, solanezumab, lemternetag, and any therapeutic agent that can be delivered by devices 11, 12, 13, 100, and 200. Agents such as those used in devices 11, 12, 13, 100, and 200 may be formulated with one or more excipients.

Referring initially to FIG. 1, an exemplary embodiment of a drug delivery device 11 is shown. The drug delivery device 11 extends from a proximal end 19 to a distal end 18 and includes a housing 15, a first motor 22, a drive system 25, a cartridge 30 configured to hold a medicament, and a needle assembly 50. In the illustrated embodiment, the drug delivery device 11 is configured such that the distal end 18 is positioned near the skin of a patient such that the needle assembly 50 can deliver the medicament from within the cartridge 30 to the patient. The cartridge 30 may also be described as a cassette or syringe and is generally configured to contain and at least partially deliver a medicament.

The cartridge 30 further comprises a fluid housing or barrel 31, a plunger or stopper 33, and a septum 35. The medication is retained within the fluid housing 31 by the stopper 33. Activation of the first motor 22 actuates the drive system 25 to drive the stopper 33 downward, forcing the medication towards the septum 35 and ultimately through the needle assembly 50. The first motor 22 can be controlled by a motor controller (not shown) to regulate the force applied to the drive system 25 and/or the speed at which the drive system 25 is actuated.

The needle assembly 50 further comprises a first needle 51, a second needle 53, a needle drive mechanism 55 coupled to the first and second needles 51, 53, and an optional second motor 57 configured to actuate the needle drive mechanism 55. Activation of the second motor 57 actuates the needle drive mechanism 55, driving the first needle 51 toward the distal end 18 and the second needle 53 toward the proximal end 19 to an extended configuration in which the first needle 51 at least pierces the patient's skin and the second needle 53 pierces the septum 35. In some embodiments, the drug delivery device 11 includes only the first motor 22 and does not include the second motor 57. In such embodiments, the first motor 22 may be coupled or connected to the needle drive mechanism 55 such that activation of the first motor 22 can further actuate the needle drive mechanism 55. In such an embodiment, the first motor 22 can actuate different aspects of the drug delivery device 11 via a clutch mechanism. As described in more detail below, the first needle 51 and the second needle 53 are fluidly coupled to one another to allow the medicament to flow from the cartridge 30, through the second needle 53, through the first needle 51, and ultimately to the patient.

The drug delivery device 11 may be configured as a single device and may also be configured to be disposable after use. In the illustrated embodiment, the cartridge 30 and needle assembly 50 are fixedly coupled to and/or are an integral part of the drug delivery device 11. The cartridge 30 may contain a single dose of drug to be delivered, or may contain drug to be delivered in multiple doses/injections. In an embodiment in which the cartridge 30 contains multiple doses of drug, the first motor 22 may be configured to push only a portion of the drug in the cartridge 30 for each dose, and the needle assembly 50 may include multiple sets of needles to inject one or more drugs into the patient.

2, to which reference is now made, shows another embodiment of the drug delivery device 12. The drug delivery device 12 functions similarly to the drug delivery device 11 of FIG. 1 and includes similar components. However, the drug delivery device 12 differs from the drug delivery device 11 in that the cartridge 30 and needle assembly 50 are removable from the housing 15, which is a reusable or durable housing component. The needle assembly 50 and the cartridge 30 may be separate components from each other or may be one single component. In the illustrated embodiment, the housing 15, the first motor 22, the drive system 25, and the second motor 57 may all be part of a reusable housing, and the cartridge 30 and needle assembly 50 may be disposable. In such an embodiment, the user may insert, use, and remove multiple cartridges 30 and needle assemblies 50 together or separately. As with the drug delivery device 11, the cartridge 30 of the drug delivery device 12 may still contain a single dose or multiple doses of a drug. The cartridge 30 and needle assembly 50 may be coupled to the housing 15 of the drug delivery device 12 by any suitable coupling mechanism, including, but not limited to, threading, bayonet couplers, screws, rivets, snaps, ball detent mechanisms, spring systems, pins, magnets, friction fit, adhesives, or other suitable coupling devices, and combinations thereof. In embodiments where the cartridge 30 and needle assembly 50 are separate components, any suitable coupling device, such as those described above, may also be used to couple the cartridge 30 and needle assembly 50. In the illustrated embodiment, the second motor 57 is coupled to the housing 15 and is not shown as part of the needle assembly 50 or cartridge 30, but instead couples to the needle assembly 50 when the needle assembly 50 is coupled to the housing 15. In other embodiments, the second motor 57 may be part of the needle assembly 50 and may be coupleable and separable to the housing 15 with the needle assembly 50.

3, to which reference is now made, shows another embodiment of the drug delivery device 13. The drug delivery device 13 is similar to the drug delivery device 11 of FIG. 1 and the drug delivery device 12 of FIG. 2, except that the cartridge 30 is fixedly coupled to the housing 15 and the needle assembly 50 is removably coupled to the housing 15. The needle assembly 50 may be disposable, while the cartridge 30 and/or the housing 15 are reusable. In the illustrated embodiment, the housing 15 and cartridge 30 may be used multiple times with different numbers of needle assemblies 50. In some embodiments, the cartridge 30 may be refillable with medicament. As previously described with respect to the drug delivery device 12, the needle assembly 50 may be coupled to the housing 15 by any suitable coupling device or system. Additionally, the second motor 57 may be part of the housing 15 or the needle assembly 50. Additional embodiments, configurations, and details of drug delivery devices and their components are discussed below.

4-5, to which reference is now made, a cassette 100 for another embodiment of a drug delivery device, such as the drug delivery device of FIG. 2, is shown. The cassette 100 includes one or more of a housing 115, a stopper drive system 120, a cartridge 130 that may be coupled to or integrally formed with the housing 115, a stopper 133, a fluid housing 131, a septum 135, a cassette ID 175, an orientation mechanism 180, a needle assembly 400, and a needle assembly actuation gear 154. The cassette 100 may also include a reusable or durable housing (not shown) to which the housing 115 may be coupled. The reusable housing may also include several motors, such as the first motor 22 and the second motor 57 described above, as well as a controller, a processor, a memory, a user interface, and/or other features configured to interact with the cassette 100.

The cassette 100 is configured to hold a quantity of medication within the fluid housing 131 and deliver the medication to a patient in a manner similar to devices 11, 12, and 13 described above. Actuation of the needle assembly actuation gear 154 extends the needle assembly 400 (see FIG. 29 ) to pierce the septum 135 with the first needle and to pierce a surface such as the patient's skin with the second needle. The cassette 100 may also include a sealant 195 configured to seal at least a portion of the needle assembly 400 within the cassette 100 prior to extension of the second needle. The sealant 195 may also maintain a sterile environment within the cassette 100. When extended, the needle assembly 400 provides fluid communication between the fluid housing 131 and the second needle. A motor and/or a user-activated actuator (e.g., a button, knob, plunger, etc.) then causes the stopper 133 to expel the medication from the fluid housing 131 through the needle assembly 400 and to the patient. The needle assembly 400 can then be retracted by actuation, such as reverse actuation, of the needle assembly actuation gear 154.

The orientation mechanism 180 is configured to orient at least a portion of the cassette 100 to rotate about the central axis A1. For example, the orientation mechanism 180 can orient the housing 115 in a particular angular orientation relative to the reusable housing or relative to the motor or actuator. In the illustrated embodiment, the orientation mechanism 180 is shown as a radial protrusion. The reusable housing or other device, including the motor or actuator, includes a complementary recess or slot for receiving the orientation mechanism 180. Thus, when a user couples the cassette 100 to the reusable housing, the cassette 100 can be constrained to a particular orientation relative to the reusable housing. Upon achieving the desired orientation, the motor or other actuator can be operably coupled to the needle assembly actuation gear 154 and/or the stopper drive system 120. The desired orientation can also position the cassette ID 175 so that it can be read or scanned by a cassette ID reading system. Additionally, the orientation mechanism 180 may orient the cassette 100 against the patient's skin and/or may orient the needle assembly 400 relative to any other components of the cassette 100. Although the orientation mechanism 180 is shown as a protrusion, the orientation mechanism 180 may be a slot that interfaces with a protrusion on the reusable housing. Additionally, the orientation mechanism 180 may be a gear, a ramp or curved surface, a knob, multiple protrusions or slots, a screw, or any other mechanism configured to orient the cassette 100. In another embodiment, the loading of the cassette into the reusable housing is axial, although there are other embodiments in which the loading of the cassette into the reusable housing is radial.

Any of the components of the cassette 100, such as the housing 115, the cartridge 130, and/or the fluid housing 131, may be constructed from a polymer. Utilizing a polymer cartridge instead of a standard glass cartridge provides greater flexibility in manufacturing the cassette 100. For example, a polymer cartridge can be shaped differently than a standardized glass cartridge, allowing for a more compact design while maintaining the same volume as a standard glass cartridge.

Additionally, polymer cartridges can be more easily manufactured, disposed of, and/or recycled as compared to glass cartridges. Additionally, polymer cartridges can be manufactured to directly interact with or mate with other components of cassette 100. For example, cartridge 130 can be manufactured with integral mating features or can be integrally formed with needle assembly 400 such that it can mate with needle assembly 400 without the need for additional mating components (e.g., fasteners). As another example, cartridge 130 can be coupled to or integrally formed with housing 115, as discussed above.

The use of polymeric materials can reduce the form factor or aspect ratio of the cassette 100 compared to cassettes utilizing standard glass cartridges, allowing for more compact or efficient packaging. The cassette 100 can have a height of less than 75 mm, less than 70 mm, less than 65 mm, less than 60 mm, less than 55 mm, less than 50 mm, less than 45 mm, less than 40 mm, or any range including any two of these values as endpoints. The cassette 100 can have a diameter of less than 50 mm, less than 45 mm, less than 40 mm, less than 35 mm, less than 30 mm, less than 25 mm, less than 20 mm, less than 15 mm, or any range including any two of these values as endpoints. More specifically, the cassette can have a height of 45 mm to 60 mm and a diameter of 25 mm to 35 mm. Stated another way, the cassette 100 can have a height:diameter aspect ratio of X:Y, where X and Y are each independently 5, 4.75, 4.5, 4.25, 4, 3.75, 2.5, 3.25, 3, 2.75, 2.5, 2.25, 2, 1.75, 1.5, 1, or any range including any two of these values as endpoints. For example, the cassette 100 can have an aspect ratio from 2:1 to 1:1.

Reducing the aspect ratio of the cassette 100 and/or cartridge 130 may also reduce the distance the stopper or plunger must travel to deliver the drug. A standard 1.6 mL glass cartridge has an inner diameter of about 9.25 mm, and may require the stopper to travel at least 14 mm to fully deliver 1 mL of drug from the cartridge. A standard 3.0 mL glass cartridge has an inner diameter of about 9.7 mm, and may require the stopper to travel at least 13 mm to fully deliver 1 mL of drug from the cartridge. Alternatively, the cartridge 130 of the cassette 100 may require a stopper travel distance of less than 10 mm, less than 9 mm, less than 8 mm, less than 7 mm, less than 6 mm, less than 5 mm, or any range including any two of these values as endpoints, to fully deliver the drug from the cartridge 130. Stated another way, the ratio of the travel distance of the stopper 133 to the inner diameter of the cartridge 130 to fully deliver the drug may be A:B, where A and B are independently 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, or any range including any two of these values as endpoints. For example, the ratio of A:B may be 1:1 to 1:3, or more specifically 1:1.5 to 1:2.5. "Fully delivered" indicates that the drug has essentially been completely emptied from a full cartridge. The reduction in the travel length of the stopper may reduce the complexity of moving parts within the cassette 100 or the entire drug delivery device. The volume of the cassette may provide any volume of drug, such as 0.5 mL, 1.0 mL, 2.0 mL, 3.0 mL, 10 mL, etc.

In the illustrated embodiment, the cassette ID 175 is disposed on the orientation mechanism 180. The cassette ID 175 can be any type of mechanism or device that provides data regarding the components of the cassette 100. For example, the cassette ID 175 can include a chip, an RFID indicator, a unique coding pattern, and/or an antenna that provides data regarding the type of drug in the cassette 130 (e.g., the specific drug, viscosity, volume, dosage, injection schedule, etc.). The cassette ID 175 can also provide data related to the orientation or assembly of the cassette 100 (e.g., indicating whether the device is fully or properly assembled, whether the device is in the proper orientation, etc.). The cassette ID 175 can provide data from a sensor or sensors in the cassette 100, such as a position sensor, a fluid level sensor, a damage or failure sensor, a battery level sensor, and/or a pressure sensor.

6-7, to which reference is now made, another embodiment of cassette 200 is shown. Cassette 200 is similar in overall operation to cassette 100 and includes similar components. Cassette 200 includes housing 215, stopper drive system 220, cartridge 230, stopper 233, fluid housing 231, septum 235, cassette ID 275, needle assembly 401, and needle assembly actuation gear 254. Cassette 200 and its components function similarly and have similar characteristics as corresponding components of cassette 100. Additionally, any reference herein to cassette 100 may also apply to cassette 200.

The cassette 200 also includes an external gear 280 configured to interface with the needle assembly actuation gear 254 to actuate the needle assembly 401. A motor or user-activated actuator from the reusable module can rotate the external gear 280, which in turn rotates relative to the lower housing 410 and the cartridge 230, and can rotate the needle assembly actuation gear 254 to actuate the needle assembly 401, as described in more detail herein. The external gear 280 may include an external gear or other interface feature driven by a motor or other actuation device, such as a second motor 57. The cassette 200 may be configured such that it can be oriented in any axial/rotational position about the central axis A1 when coupled to a reusable or reusable housing. Although the cassette 100 includes an orientation mechanism 180 for orienting the cassette 100 relative to the housing, the cassette 200 may not require a similar orientation. In some embodiments, the external gear 280 can function as an orientation mechanism similar to the orientation mechanism 180 to rotate the cassette 200 or its components about the central axis A1. A clutch or similar mechanism can be used to rotate all or part of the cassette 200 by rotating the external gear 280, and the clutch can be actuated to rotate the external gear 280, which in turn rotates the needle assembly actuation gear 254. Thus, the external gear 280 can be utilized to orient the components of the cassette 200 relative to the reusable housing, motor, or another device external to the cassette 200. In some embodiments, the cassette 200 does not need to be oriented relative to any other components and can be assembled or coupled with the reusable housing at any axial position.

The cassette ID 275 of the cassette 200 can be implemented in a way that avoids a particular angular orientation. For example, the cassette ID 275 is shown as a series of concentric rings on the proximal end of the cassette 200. The cassette ID 275 may be referred to as a circular cassette ID. The cassette ID 275 functions similarly to the cassette ID 175, but is located and laid out differently. Because the cassette ID 275 extends completely around the proximal end of the cassette 200, the cassette ID 275 may be read when the cassette 200 is in any rotational position along its central axis A1. Thus, the cassette 200 may not require a rotational orientation to allow the cassette ID 275 to be read. Additionally, in an embodiment in which the cassette 200 may be rotated by the external gear 280, the cassette ID 275 may still be read from any rotational position.

8, the stopper drive system 120 is shown. The stopper drive system 120 includes a driven body 122, a drive screw 123, and an interface end 121. The interface end 121 is configured to interface with a motor or another actuator (e.g., a knob). Rotation of the interface end 121 causes rotation of the drive screw 123. The drive screw 123 threads with the driven body 122 such that rotation of the drive screw 123 moves the driven body 122 up and down along the central axis A1. The driven body 122 may be in direct contact with the drug in the fluid housing 131 (FIG. 5) or may be in contact with a stopper that contacts the drug. Actuation of the stopper drive system 120 pushes the drug out of the fluid housing 131. All the features of the stopper drive system 120 may also be applied to the drive system 220 of the cassette 200. Other exemplary embodiments of the drive system 250 are described in PCT Publication No. WO2019/112886, the entire disclosure of which is incorporated herein by reference.

9-10, the first motor 22 is operably coupled to the stopper drive system 120 such that activation of the first motor 22 actuates the stopper drive system 120. Additionally, the cassette 100 optionally includes a second motor 57 (shown in FIGS. 1-3) configured to actuate a needle mechanism, such as any of the needle mechanisms 55, 390, 590 described herein. The cassette 100 may also optionally include a third motor 58 configured to drive the orienting mechanism 180 in embodiments in which the orienting mechanism 180, 280 is a gear or another actuable device. In embodiments in which the drug delivery device does not include a second motor 57, the first motor 22 may be configured to actuate the needle mechanism 55, 390, 590. In embodiments in which the drug delivery device does not include a third motor 58, the first motor 22 may be configured to actuate the orienting mechanism 180. In embodiments in which the orientation mechanism 180, 280 can also actuate the needle mechanism 55, 390, 590, the second motor 57 or the third motor 58 can actuate both the orientation mechanism 180, 280 and the needle mechanism 55, 390, 590.

Each of the motors 22, 57, and 58 may be coupled to the reusable housing of the cassette 100 and/or may be coupled to the cartridge 130. In some embodiments, at least one of the motors 22, 57, and 58 is coupled to the reusable housing, and the orientation mechanism 180 is configured to orient the cartridge 130 relative to the reusable housing and the at least one motor 22, 57, 58 such that the cartridge 130 and/or components of the cartridge 130 are operably coupled to the at least one motor 22, 57, 58. For example, the orientation mechanism 180 may be configured to orient the cartridge 130 such that the stopper drive system 120 is operably coupled to the motors 22, 57, 58. The orientation mechanism may orient the needle assembly 300, 400, 401, 500 relative to the reusable housing or the motor such that the needle assembly 300, 400, 401, 500 and/or the needle mechanism 55, 390, 590 are operably coupled to the motor 22, 57, 58.

In one embodiment, a disposable medication cassette unit is provided for attachment and detachment from a reusable housing unit configured to receive the cassette unit. The cassette unit includes a cassette unit body extending along a central axis A1 between a proximal end and a distal end. The proximal end and the distal end may be defined by a plane extending perpendicular to the central axis A1. Extending beyond the proximal end of the cassette unit is an interface end of a stopper drive system. The interface end is exposed outside the body of the cassette unit and disposed along the central axis A1. The unit body includes a proximal sleeve portion extending along the proximal portion of the cassette and a distal portion surrounding the needle assembly. There may be an intermediate portion between the portions made of a material that allows the cassette housed therein to be viewed.

Each of the first motor 22 and the optional second motor 57 and the optional third motor may be controlled by a motor controller 260. As used herein, the term "logic" or "control logic" may include software and/or firmware executed on one or more programmable processors, application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), digital signal processors (DSPs), hardwired logic, or combinations thereof. Thus, various logic may be implemented in any suitable manner according to an embodiment and remain in accordance with the embodiments disclosed herein. The controller 260 may be included in the cassette 100 or may be external. The controller 260 may include at least one processor 262 (e.g., a microprocessor) that executes software and/or firmware stored in the memory 264 of the controller 260. The software/firmware code includes instructions 265 that, when executed by the processor 262, cause the controller 260 to perform the functions of the control algorithms described herein. The controller 260 may receive information from multiple system components and provide that information (e.g., medication data, patient data, drug delivery device data, needle assembly data) to a control algorithm that determines at least one drug delivery control parameter that may in part control the operation of the first motor 22, the second motor 57, and/or the third motor 58. The controller 260 may include or be communicatively coupled to one or more interfaces for communicatively coupling to the cassette 100 via one or more communication links. Exemplary interfaces include wired and wireless signal transmitters and receivers. Exemplary communication links include wired communication links (e.g., serial communications), wireless communication links such as short-range wireless links such as Bluetooth, IEEE 802.11, proprietary wireless protocols, and/or the like. The term "communication link" may refer to the ability to communicate any type of information in at least one direction between at least two devices. The communication link may be a persistent communication link, an intermittent communication link, an ad-hoc communication link, and/or the like. The information may be transmitted over a communications link.

10 illustrates a controller 260 including a memory 264 and a processor 262 communicatively coupled to one or more interfaces 268. The memory 264 may include computer readable storage media in the form of volatile and/or non-volatile memory and may be removable, non-removable, or a combination thereof. In an embodiment, the memory 264 stores executable instructions 265 (e.g., computer code, machine usable instructions, etc.) for causing the processor 262 to perform aspects of the embodiments of the system components discussed herein and/or execute aspects of the embodiments of the methods and procedures discussed herein, including control logic described in more detail below. The memory 264, the processor 262, and the interface 268 may be communicatively coupled by one or more buses. Data and/or information may be provided to the controller 260 as it is retrieved on a predefined schedule, or may be queued in the memory and supplied to the controller 260 when requested.

The logic of the controller 260 may be configured to adjust the actuation speed or force of actuation provided by the first motor 22, the second motor 57, and/or the third motor 58. For example, if the drug in the cartridge 130 is viscous, the force applied by the first motor 22 to drive the stopper 133 may be increased. In a further example, the actuation speed of the first or second motors 22, 57 may be adjusted to change the actuation speed of the needle mechanism. The needle mechanism may actuate more slowly to improve patient comfort and reduce irritation. In some embodiments, the controller may change the operating parameters of the first and/or second motors 22, 57 based on the received information/data (e.g., patient data, drug data, usage history data, dosage data, drug delivery device data, needle assembly data, cartridge data). Additionally, the controller 260 may be configured to change the speed of the motors 22, 57 during actuation so that the movement of the stopper drive system 120 and/or the needle mechanism is not constant or nonlinear. For example, the needle mechanism may be actuated to decelerate the needle near the end of its travel to prevent a hard stop. The controller 260 may control the timing of motor activation, such as, for example, activating the first motor 22 before the second motor 57. The controller 260 may also receive data based on the needle position indicating the position of at least one needle in the needle assembly, and may modify the speed, force, or position of the at least one needle based on the position data.

11-14, to which reference is now made, an exemplary embodiment of a needle assembly 300 is shown. Any of the illustrated needle assemblies or variations thereof may be used within the cassette 100. Additionally, the disclosed needle assemblies may be used separately from the cassette 100, for example, in a chemical sampling instrument or other applications in which needles are used. The needle assembly 300 includes an assembly housing 310, an inner housing 312, a first needle support 320 coupled to a first needle 330, a second needle support 340 coupled to a second needle 350, a movable connector 360, a drive member 370, and an O-ring 380. Additionally, the needle assembly 300 includes an outer seal 395 and an inner seal 396. The first needle support 320, the first needle 330, the second needle support 340, the second needle 350, the movable connector 360, and the movable connector 360 together constitute a needle mechanism 390. The external sealant 395 and the internal sealant 396 are configured to seal the needle mechanism 390 within the needle assembly 300 before the needle assembly 300 is used and to help maintain sterility within the needle assembly 300. In some embodiments, the internal sealant 396 may not be included and the bond between the needle assembly 300 and the remainder of the cassette 100 may maintain sterility. A description of aspects of the drug delivery device and needle assembly 300 is described in PCT Publication No. WO2022/132675, filed December 14, 2021, and entitled "FLUID DELIVERY SYSTEM WITH NEEDLE ASSEMBLY."

In the illustrated embodiment, the needle assembly 300 is configured to interact with the patient's skin to deliver the medicament described above. A first or distal end 392 of the needle assembly 300 is placed against the skin, and a second or proximal end 394 of the needle assembly 300 interacts with the cartridge 130. The needle assembly 300 is configured to couple to the cartridge 130 directly or via a needle assembly coupler 210. The first end 392 and/or the exterior sealant 395 may include an adhesive to aid in placing the needle assembly 300 against the patient's skin, and may also include a fastener or adhesive to secure the needle assembly 300 to the cartridge 130. As shown in FIG. 14, the inner housing 312 is supported by the housing 310, and the needle mechanism 390 is supported by the inner housing 312. In other embodiments, the needle assembly 300 may include only one housing, and the inner housing 312 may be integral with the assembly housing 310.

Referring to FIG. 14, the needle mechanism 390 is configured to fit completely within the needle assembly 300 when in the first configuration. FIGS. 14-18 show various views of the needle mechanism 390 in the first configuration. In the first configuration, the first needle 330 and the second needle 350 are aligned substantially parallel to one another in the direction of the central axis A1. As shown, the first needle 330 and the second needle 350 are oriented in substantially opposite directions along the axis A1. The first needle 330 is oriented toward the first end 392 of the needle assembly 300, and the second needle 350 is oriented toward the second end 394 of the needle assembly 300. As will be described below, the first needle 330 and the second needle 350 are configured to move substantially along the axis A1 when the needle assembly 300 is activated.

15-18, an exemplary embodiment of the needle mechanism 390 is shown. The first and second needle supports 320, 340 are disposed generally along a common plane and slidably coupled to each other via the drive member 370. A first side of the first and second needle supports 320, 340 is configured to interact with the drive member 370, and a second side of the first and second needle supports 320, 340 is configured to interact with and support the first and second needles 330, 350. In the illustrated embodiment, the first and second needle supports 320, 340 are generally rectangular in shape and are configured to fit within the needle assembly 300 as shown in FIG. 20. In other embodiments, the first and second needle supports 320, 340 may be any shape that accommodates the movement of the needles 330, 350 and fits within the needle assembly 300. In the illustrated embodiment, the needle mechanism 390 comprises a rack and pinion arrangement, with each of the first needle support 320 and the second needle support 340 being a rack, and the drive member 370 including a pinion gear. The first needle support 320 comprises a support 324, a support engagement feature 322, and a needle holder 326. The needle holder 326 is configured to couple with the first needle 330 by inserting at least a portion of the first needle 330 into the needle holder 326, thereby coupling the first needle 330 to the first needle support 320. Similarly, the second needle support 340 comprises a support 344, a support engagement feature 342, and a needle holder 346, and the second needle 350 is coupled to the second needle support 340 via the needle holder 346. As best shown in FIGS. 16 and 18, one or both of the first needle support 320 and the second needle support 340 may further include a needle guard 352 that may function to protect and/or provide additional strength to the needle. An exemplary needle guard 352 is a cylindrical housing having a bore extending therethrough through which the respective needle 330, 350 extends.

The first needle 330 and the second needle 350 are fluidly coupled to each other via a movable connector 360. The movable connector 360 is configured to be movable relative to each of the needles 330 and 350. The movable connector 360 can be movable by bending, curving, stretching, or otherwise deforming. Thus, the movable connector 360 can be constructed of a flexible material such as an elastomer, a thermosetting polymer, or a rubber. In an exemplary embodiment, the movable connector 360 is constructed of silicone. In another embodiment, the movable connector 360 can be constructed of a rigid material coupled to each other via a flexible connection. In yet another embodiment, the movable connector 360 can be formed of a relatively rigid material and can be moved by a stretching motion. In the illustrated embodiment of FIG. 24, the movable connector 360 is a flexible tube having a first end 362 fluidly coupled to the end of the first needle 330 and a second end 364 fluidly coupled to the end of the second needle 350. The flexible tube ends 362, 364 of the movable connector 360 may be directly coupled to the needle ends 330, 350 or to the respective needle holders 326, 346. As described further below, the flexible tube ends 362, 364 are configured to move with the needles 330, 350.

As best shown in FIGS. 19-20, the drive member 370 includes a drive engagement feature 372 and an actuation member 374. An O-ring 380 may be provided on the drive member 370 to provide a better seal between the drive member 370 and the assembly housing 310 or to allow the drive member 370 to rotate more easily within the assembly housing 310. The drive engagement feature 372 is configured to interact with the support engagement features 322 and 342 (FIG. 17). In the illustrated example, the drive engagement feature 372 and the support engagement features 322 and 342 are teeth or protrusions configured to mesh with each other in a rack and pinion mechanism. In other embodiments, any of the engagement features in the needle mechanism 390 may be other features configured to interact with each other, such as protrusions and recesses, screws and threads, zipper-type features, or any other complementary engagement features. Additionally, in the illustrated example, the actuation member 374 is configured to be actuated by the rotation of a flat object, such as a flat head screwdriver. In other embodiments, the actuating member 374 may be actuated by an electric motor, a torsion spring, or human interaction such as the turning of a knob. In one exemplary embodiment, both the stopper drive system 120 and the drive member 370 are each independently driven by an electric motor, such as the first motor 22 and the second motor 57 (FIG. 9). A single electric motor may control the movement of both the stopper drive system 120 and the drive member 370, or they may have their own respective actuation motors.

21-22, to which reference is now made, the needle mechanism 390 is configured to permit movement of the first needle support 320 and the second needle support 340 upon actuation of the drive member 370. The needle mechanism 390 is movable between a first retracted configuration before and/or after use, as shown in FIG. 27, and a second extended configuration during use, as shown in FIG. 28. The needle mechanism can return to a third retracted configuration after use to indicate to the patient that the injection is complete and to hide the needle within the assembly, thereby eliminating the need for the patient to see or handle the needle when discarding the cassette.

In the first retracted configuration of FIG. 21, both the first needle 330 and the second needle 350 are fully axially disposed within the assembly housing 310. The movable connector 360 is disposed in compression (e.g., bent or looped) between the approximated tube ends 362, 364 and the needles 330, 350, and the approximated tube ends 362, 364 are separated by a first distance. When the drive member 370 rotates in the C1 direction, the first needle support 320 and the first needle 330 are driven in the D1 direction, and the second needle support 340 and the second needle 350 are driven in the D2 direction, until the needle mechanism 390 is in the second configuration and the rotation of the drive member 370 stops. In the illustrated embodiment, D1 and D2 are substantially parallel in a plane and substantially opposite each other. Furthermore, they are substantially parallel to the axis A1 (see FIG. 14). In other embodiments, D1 and D2 may be angled relative to each other and may not be substantially parallel to A1.

In the second extended configuration, the first needle 330 extends axially beyond the assembly housing 310, passes through the exterior seal 395, and enters the surface on which the needle assembly 300 is disposed. Additionally, the second needle 350 extends axially beyond the assembly housing 310, passes through the interior seal 396 and the septum 135, and enters the fluid housing 131. The movable connector 360 is movable to maintain fluid communication between the first needle 330 and the second needle 350 during movement of the needle mechanism 390. The movable connector 360 may be disposed in an extended state between the remote tube ends 362, 364 and the needles 330, 350 in the second configuration, where the remote tube ends 362, 364 are separated by a second distance that is greater than the first distance in the first configuration. In the second configuration, the first needle 330 is fluidly coupled to the cartridge 130 such that the medicament in the fluid housing 131 can flow through the second needle 350, the movable connector 360, and the first needle 330 to the body or surface pierced by the first needle 330. In an exemplary embodiment, the stopper drive system 120 is activated after the needle mechanism 390 is in the second configuration, and the medicament in the cartridge 130 is forced into the body or surface pierced by the first needle 330. In another embodiment, some components of the needle mechanism 390 and/or the inner housing 312 include a stop feature that physically stops the movement of the first needle support 320 and the second needle support 340 when the needle mechanism 390 reaches the second configuration. Such a stop feature can be a blocking member, a protrusion, a detent, or the absence of an engagement member in a portion of the needle mechanism 390.

From the second configuration, the needle mechanism 390 is similarly configured to return to the first configuration by reverse actuation of the drive member 370. As shown in FIG. 22, the drive member 370 can be rotated in a direction C2 generally opposite to C1 to drive the first needle support 320 in direction D2 and the second needle support 340 in direction D1. In an exemplary embodiment, the needle mechanism 390 is moved from the second configuration to the first configuration after the drug is pushed out of the cartridge 130 through the needle mechanism 390. In an embodiment in which the cassette 100 is used to deliver the drug to a patient, by extending the first needle 330 from the needle assembly 300 and retracting the first needle 330 into the needle assembly 300 after injection, the patient can inject the drug without having to directly view or handle the first needle 330.

23-24, to which reference is now made, another embodiment of a needle assembly 500 is shown. The needle assembly 500 includes a housing 510, a rotating assembly 514, and a plurality of needle mechanisms 590. Each needle mechanism 590 includes a first needle support 520 coupled to a first needle 530, a second needle support 540 coupled to a second needle 550, a movable connector 560, a drive member 570, a drive member actuator 578, and an O-ring 580. In the illustrated embodiment, multiple needle mechanisms 590 are shown, but any number of needle mechanisms 590 can be used, including a single needle mechanism 590, as in the embodiment shown in FIG. 11. The movable connector 560 can have various features in common with the movable connector 360 described above.

The rotating assembly 514 includes an exposed driven gear 512 and is configured to couple with the housing 510. In an exemplary embodiment, the driven gear 512 is driven by a motor to rotate the housing 510 via the rotating assembly 514. In other embodiments, the rotating assembly 514 may not include a driven gear 512 and may instead have a different user feature that facilitates its rotation, such as a grip rotated by a motor or other engagement feature rotated by another device. In yet other embodiments, the rotating assembly 514 may be configured to rotate only the needle mechanism 590 within the housing 510 instead of rotating the entire needle assembly 500.

25-28, the needle mechanism 590 of the needle assembly 500 is configured as a drive screw assembly. Each of the first and second needle supports 520 and 540 includes an engagement feature 522, a support 524, and a needle holder 526. The first and second needle supports 520 and 540 are configured to engage with the drive member 570. Each of the first and second needle supports 520, 540 is generally curved to accommodate interaction with the drive member 570 and is configured to position the first and second needles 530, 550 generally adjacent to one another. In other embodiments, the first and second needle supports 520, 540 may be configured to position the first and second needles 530, 550 on opposite sides of a central axis from one another. Each engagement feature 522 is configured to interact with a drive engagement feature 572 of the drive member 570. In the illustrated embodiment, the engagement feature 522 is threadedly engaged with the drive member 570. The engagement feature 522 is shown as a screw thread and the drive member 570 is shown as a threaded shaft such as a screw, with the drive engagement feature 572 being a trough or root in the screw. The engagement feature 522 is configured to be received within or otherwise interact with the drive engagement feature 572 of the drive member 570. In the illustrated embodiment, the drive engagement features 572 of the drive member 570 are oppositely oriented along opposing halves of the drive member 570 such that rotation of the drive member 570 causes opposite axial movement of the first and second needle supports 520, 540. A drive gear 578 is coupled to each drive member 570 such that rotation of the drive member actuator 578 causes rotation of the drive member 570. The drive member 570 also includes at least one stop feature 573 configured to stop movement of the first needle support 520 and/or the second needle support 540 along the drive member 570. In the illustrated embodiment, the drive member 570 includes a stop feature 573 on each half of the drive member 570.

28, needle mechanism 590 can be extended and retracted similarly to needle mechanism 390, but uses a different drive mechanism. More specifically, needle mechanism 590 can be moved between a first retracted configuration before and/or after use and a second extended configuration during use (not shown), as shown in FIG. 38. Within needle mechanism 590 of needle assembly 500, drive member actuator 578 is rotatably locked to drive member 570, such that rotation causes rotation of drive member 570. Engagement features 522 on first needle support 520 and second needle support 540 are configured to move first needle support 520 and second needle support 540 in opposite axial directions along drive member 570 as drive member 570 rotates. Each needle mechanism 590 begins in a first configuration, as shown in FIG. 38 , and rotating the drive member 570 in a first direction causes the first needle support 520 to move in direction D1 and the second needle support 540 to move in direction D2, thereby moving the needle mechanism 590 to the second configuration. Actuation of the member actuator 578 stops the movement of the first needle support 520 and the second needle support 540 when the needle mechanism 590 reaches the second configuration. The drive member 570 can then be rotated in a second, opposite direction to move the needle mechanism 590 from the second configuration to the first configuration by moving the first needle support 520 in direction D2 and the second needle support 540 in direction D1. As discussed with respect to the needle assembly 300, all of the foregoing disclosures relating to the first configuration, second configuration, needles, uses, etc., may be applied to the needle assembly 500. By utilizing a screw mechanism, such as needle assembly 500, needle assembly 500 can occupy less space than rack and pinion mechanisms, such as needle assemblies 300 and 400.

One or more advantages may be realized by any of the cassettes having any of the needle mechanisms disclosed herein, where the needle mechanism is movable between a first configuration and a second configuration, where a fluid path is formed (first configuration) and removed (second configuration) between the drug reservoir and the needle for injecting the patient, i.e., the fluid path between the drug reservoir and the needle for injecting the patient is separated. One advantage of this separation is that the accuracy of the dose delivery may potentially be improved since there is no sagging due to the plunger decompression (which can maintain a slight internal pressure). This may result in a shorter retention time of the device at the treatment site by the patient, and a higher accuracy of the dose may be achieved. One or more advantages of the gear mechanism and needle support described herein is that it provides very tight guidance of the needle movement. Thus, such tightly guided control may more effectively hit small septum targets and/or push the needle straight out of the patient's skin (less likely to hit a proximal nerve).

As shown in FIG. 25, multiple needle assemblies can be used. Additional details regarding the use of multiple needle assemblies, as well as needle assemblies that can operate with two needles oriented along different axes (e.g., perpendicular needles), are described in the above-incorporated U.S. Provisional Application No. 63/126,552.

29-30, to which reference is now made, there is shown a needle assembly 400 configured for use with the needle mechanism 390. The needle assembly 400 may have similar functionality to the needle assembly 300 as described above. The assembly 400 may have a lower tubular body and a middle portion extending axially from the lower tubular body. The lower tubular body may define a radial recess in which the gear 154 resides (with the face of the gear facing radially outward). The axis of rotation of the gear 154 may be perpendicular to the central axis as shown in the figures. The middle portion forms an enclosure around the needle mechanism 390. The middle portion may include a radial opening through which the shaft from the gear 154 extends into the middle portion in a radially inward orientation. The middle portion may include an opening through which the needle from the needle mechanism 390 selectively passes. The needle assembly actuation gear 154 is configured to actuate the drive member 370, thereby actuating the needle mechanism 390. As mentioned above, the actuation gear 154 can be actuated by a motor within a reusable housing or manually by a user.

31-32, to which reference is now made, there is shown a needle assembly 402 configured for use with the needle mechanism 590. The needle assembly 402 may have similar functionality to the needle assembly 500 described above. The needle assembly actuation gear 155 is configured to mesh with and rotate with the drive member actuator 578, thereby actuating the drive member 570 and actuating the needle mechanism 590. The assembly 402 may have a lower tubular body and an intermediate portion extending axially from the lower tubular body. The lower tubular body may define a recess (the face of the gear facing axially) in which the shaft of the gear 155 resides. The intermediate portion forms an enclosure around the needle mechanism 590. The intermediate portion may include a first axial opening through which the drive member 570 passes. The drive member actuator 578 is rotatably fixed to the drive member 570 and drivingly engaged with the gear 155. The intermediate portion may include another axial opening through which the needle from the needle mechanism 590 selectively extends.

33, the needle assembly 401 is shown without the needle assembly housing. The needle assembly 401 is configured to be used with the needle mechanism 390. The needle assembly 401 may have similar functions as the needle assembly 300 as described above. The needle assembly actuation gear 254 is configured to actuate the drive member 370, thereby actuating the needle mechanism 390. The gear 254 is drivable by the external gear 280. The gear 280 may be formed in a ring shape with gear drive teeth formed along the edge of its body for axially engaging the gear 254. The external gear 280 may include an at least partially circumferential radial lip 285 extending from the outer surface of the gear 280, which slidably engages the upper edge of the lower portion 410 (as shown in FIG. 7). The external gear may include one or more driven teeth or gear interface features driven by a motor or a user. The driven teeth may be circumferentially spaced apart from one another along the outer surface. In one embodiment, the driven teeth are shown as axially extending protrusions that extend away from the radial lip. The gear interface features may include recesses instead of protrusions. When the external gear 280 is rotated, for example, driven by the second motor, the gear drive teeth drivingly engage the teeth of the gear 254, thereby moving the needle as described above.

34, to which reference is now made, there is shown a needle assembly 403 configured for use with a needle mechanism 590. The needle assembly 403 may have similar functionality to the needle assembly 500 as described above. The needle assembly actuation gear 255 is configured to rotate in mesh with the drive member actuator 578, thereby actuating the drive member 570 and the needle mechanism 590. The axis of rotation of the gear 255 may be offset and parallel to the central axis as shown. The axis of rotation of the gear 578 may be offset and parallel to the central axis and offset from the axis of rotation of the gear 255 as shown. The gear 255 is drivable by an external gear 281. The gear 281 is formed in a ring shape with gear teeth formed in a radially inward orientation along the edge of its body for radial engagement with the gear 255. In one embodiment, the drive teeth or external gear interface features may be projections spaced circumferentially from one another about an axis (not shown) and extending axially along an outer surface, similar to gear 280. When external gear 281 is rotated, for example driven by a second motor, the gear drive teeth drivingly engage with teeth of gear 255 which drivingly engage with teeth of drive member actuator 578, thereby moving the needle as described above.

35, a computing device 700 may be used to communicate and/or operate with any of the drug delivery devices 11, 12, 13, 100 described herein, for example, cassette 100. The computing device 700 illustratively includes a mobile device such as a smartphone. Alternatively, any suitable computing device may be used, including, for example, but not limited to, a laptop, desktop, tablet, or server computer.

The processor 700 includes at least one processor 710 that executes software and/or firmware stored in the memory 720 of the computing device 700. The software/firmware code includes instructions that, when executed by the processor 710, cause the device 700 to perform the functions described herein. The at least one processor 710 illustratively includes control logic and/or applications 715 that operate to activate the cassette 100. The memory 720 is any suitable computer-readable medium accessible by the processor 710. The memory 720 may be a single storage device or multiple storage devices, may be located internal or external to the processor 710, and may include both volatile and non-volatile media. Exemplary memories 720 include random access memory (RAM), read-only memory (ROM), electrically erasable programmable ROM (EEPROM), flash memory, magnetic storage devices, optical disk storage, or any other suitable medium configured to store data and accessible by the processor 710.

The computing device 700 includes a user interface 705 in communication with the processor 710 and operable to provide user input data to the system and to receive and display data, information, and prompts generated by the system. The user interface 705 includes at least one input device for receiving user input and providing user input to the system. In the illustrated embodiment, the user interface 705 is a graphical user interface (GUI) including a touch screen display operable to display data and receive user input. The touch screen display allows a user to interact with presented information, menus, buttons, and other data to receive information from the system and provide user input to the system. Alternatively, a keyboard, keypad, microphone, mouse pointer, or other suitable user input device may be provided.

The computing device communicates with the cassette 100 by signal 750. Signal 750 may be a wireless or wired signal. The cassette 100 may include a processor 760 similar to the processor 710, a cassette ID 770, and/or a communication device 780. The communication device 780 may transmit or receive the signal 750 to/from the communication device 740 or to/from other components of the cassette 100 (e.g., cassette ID 770). The cassette ID 770 may be any type of mechanism or device that provides data regarding the components of the cassette 100. For example, the cassette ID 770 may be a chip or RFID indicator on the cassette 100 (FIG. 12) that provides data regarding the type of liquid or drug in the cartridge 130 (e.g., specific drug, viscosity, volume, dosage, injection schedule, etc.). Other components, such as the needle assembly or motor, may include an ID to communicate other data related to the cassette 100 (e.g., needle assembly type, needle length/position, patient information, treatment history information, motor type, motor characteristics, etc.).

In some embodiments, the cassette 100 may include an indicator (not shown) that provides some indication that the drug has been delivered to the patient. Such an indication may be an indication of end of administration. The indicator may include, for example, a visual indication such as a light (e.g., LED), a screen, a vibration, a sound, a signal transmission, an indication on another computing device (e.g., a smart phone or computer as described above), a mechanical visual indicator (e.g., a window in the device housing indicating barrel movement), or any combination thereof. The indicator may also display any other information to the user regarding the operation of the cassette 100, including, but not limited to, whether the cassette is inserted, whether the cassette is properly inserted, device power information (e.g., device on/off, battery level), patient information, information that may be provided by the IDs described above, or any combination thereof.

In some embodiments, the cassette 100 may include a number of sensors (not shown) that sense information related to the device. In an exemplary embodiment, the cassette 100 includes a skin sensor that senses whether the device is properly placed against the patient's skin. In some embodiments, if the skin sensor does not indicate that the device is properly placed, the cassette 100 may not activate the needle assembly or deliver the drug. Other examples of optional sensors include, but are not limited to, drug level sensors, pressure sensors, accelerometers, force/thrust sensors, position sensors for elements of the drive system, cartridge, housing, and/or needle assembly, pH sensors, or any combination thereof. Temperature sensors may be provided to sense ambient temperature, drug temperature, or the temperature of another component, and may be embodied, for example, but not limited to, a thermistor (e.g., a negative temperature coefficient (NTC) thermistor or a resistance temperature detector (RTD)), a thermocouple, or a semiconductor-based temperature sensor.

In some embodiments, the cassettes disclosed herein do not include a stopper drive system 120, 220. Instead, the drive system of the housing of the reusable portion is configured to engage the stopper.

Some or all of the components of the drug delivery devices disclosed herein, such as devices 11, 12, 13, 100, and 200, may be constructed from polymers or disposable materials. For example, some or all of the components of drug delivery devices 11, 12, 13, and/or cassettes 100 and 200 may be constructed from cyclic olefin polymers. Additionally, some or all of the components of cassette 100 may be manufactured by additive manufacturing, extrusion, reduction machining, casting, molding, or any other suitable manufacturing process. In some embodiments, the housing, cartridge, fluid housing, orientation mechanism, drive system, and/or needle assembly may be constructed partially or entirely from polymers. Manufacturing certain components from polymers may improve manufacturing tolerances compared to other materials, such as glass, and may also reduce the impact of waste of such devices or components.

The terms "first," "second," "third," etc., whether used herein or in the claims, are provided to distinguish between similar elements and do not necessarily describe an order or chronological sequence. It is to be understood that the terms so used are interchangeable under appropriate circumstances (unless expressly disclosed otherwise) and that the disclosed embodiments described herein are capable of operating in other orders and/or configurations than those described or illustrated herein.

While the invention has been described as having an exemplary design, the invention can be further modified within the spirit and scope of the disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.

Various aspects are described in this disclosure, including but not limited to the following aspects.
1. A drug delivery device comprising a cassette comprising: a cartridge configured to hold a quantity of medicament; a stopper drive system configured to drive the medicament from the cartridge, the stopper drive system comprising a stopper, the stopper moving less than 10 mm to deliver a quantity of 1 mL of medicament; and a needle assembly directly coupled to the cartridge and movable between an extended configuration and a retracted configuration, the needle assembly having an actuation gear movable between a first position and a second position, wherein in the extended configuration, the actuation gear is in the second position and the needle assembly provides fluid communication between the cartridge and the needle assembly, and in the retracted configuration, the actuation gear is in the first position and no fluid communication is provided between the cartridge and the needle assembly.
2. The drug delivery device according to aspect 1, further comprising a reusable housing configured to receive the cassette and including a drive system, the drive system configured to operably couple to at least the stopper drive system.
3. The drug delivery device according to aspect 2, further comprising an orientation mechanism configured to orient the cartridge relative to the reusable housing when the cartridge is coupled to the reusable housing.
4. The drug delivery device of aspect 3, wherein the orientation feature comprises a protrusion and the reusable housing comprises a slot configured to receive the protrusion.
5. The drug delivery device according to aspect 2, wherein the reusable housing is configured to receive the cassette at any rotational position about a central axis of the cassette.
6. The drug delivery device according to any one of aspects 1 to 5, further comprising a first motor configured to actuate the stopper drive system to deliver the drug from the cartridge.
7. The drug delivery device according to aspect 6, further comprising a second motor configured to actuate the actuation gear of the needle assembly.
8. The drug delivery device according to any one of the preceding aspects, wherein the cassette has a height of 40 mm to 60 mm and a diameter of 20 mm to 40 mm.
9. The drug delivery device according to any one of the preceding aspects, further comprising a cartridge ID coupled to the cartridge.
10. The drug delivery device of aspect 9, wherein the cartridge ID includes at least one circular ID, the circular ID configured to be read from a plurality of rotational orientations relative to a central axis of the circular ID.
11. The medication delivery device of aspect 9, wherein the cartridge ID comprises at least one of an RFID indicator, a readable chip, and an antenna.
12. The drug delivery device according to any one of aspects 1 to 11, wherein the cartridge and at least a portion of the stopper drive system and needle assembly are constructed from a polymer.
13. A method of delivering a medicament to a patient, comprising: coupling a housing of a drug delivery device to a cassette having a needle assembly including a first needle and a second needle, the needle assembly being in a retracted configuration where no fluid communication is provided between the cartridge and the needle assembly; orienting the housing relative to the cassette; placing the drug delivery device against the skin of a patient; actuating the needle assembly of the drug delivery device to extend the first needle into the skin of the patient and the second needle into a septum of a cartridge containing a quantity of medicament; actuating a drive system to drive a stopper from the cartridge through the needle assembly to the patient, moving less than 10 mm for a quantity of 1 mL of medicament; and retracting the first and second needles within the needle assembly, where no fluid communication is provided between the cartridge and the needle assembly.
14. The method of aspect 13, wherein the orienting step is performed by an orienting mechanism.
15. The method of aspect 14, wherein the orienting feature comprises at least one of a protrusion, a slot, and a gear.
16. The method of any one of aspects 13-15, further comprising the step of separating the housing from the cassette after the retracting step.
17. The method of any one of aspects 13-17, further comprising reading a cartridge ID on the housing.
18. A drug delivery device comprising: a reusable housing; a cassette coupled to the reusable housing, the cassette having a height to diameter ratio of 2:1 to 1:1; a cartridge supported by the cassette and configured to hold a quantity of medicament; and an orientation mechanism configured to orient the cassette relative to the reusable housing.
19. The drug delivery device according to aspect 18, further comprising at least one motor supported by the reusable housing, wherein the orienting mechanism orients the cassette to operatively couple the at least one motor with at least a portion of the cassette.
20. The drug delivery device of aspect 19, further comprising a needle assembly directly coupled to and at least partially within the cassette movable between an extended configuration and a retracted configuration, wherein in the extended configuration, the needle assembly provides fluid communication between the polymer cartridge and the needle assembly.
21. A drug delivery device including a cassette for coupling to a reusable module, the cassette comprising: a cartridge configured to hold a quantity of medicament, the cartridge extending between a proximal end and a distal end along a centrally located axis; a stopper drive system configured to drive the medicament from the cartridge, the stopper drive system including a stopper and an interface end coupled to the stopper and configured to be driven by a first motor or actuator of the reusable module to move the stopper; and a needle assembly coupled directly to the cartridge and movable between an extended configuration and a retracted configuration, the needle assembly being movable between an extended configuration and a retracted configuration. and a needle assembly, the cartridge having an actuation gear movable between a first position and a second position, the actuation gear configured to be driven directly or indirectly by a second motor or actuator of the reusable module, wherein in an extended configuration, the actuation gear is in the second position and the needle assembly provides fluid communication between the cartridge and the needle assembly, and in a retracted configuration, the actuation gear is in the first position and no fluid communication is provided between the cartridge and the needle assembly, the interface end extending from a top end of the cartridge and coaxial with the axis, the actuation gear being positioned to be externally engaged by the second motor or actuator of the reusable module at a position offset from the axis.
22. The drug delivery device of aspect 21, wherein the actuation gear further comprises an external gear in driving engagement with the actuation gear, the external gear comprising external gear interface features circumferentially spaced apart from one another about the axis, the external gear interface features configured to be driven by a second motor or actuator of the reusable module.
23. The drug delivery device of aspect 22, wherein the external gear has a ring-shaped body, the external gear interface features are disposed along a circumferential surface of the ring-shaped body, and the external gear includes gear drive teeth formed along an axial edge of the ring-shaped body for axial engagement with the actuation gear.
24. The drug delivery device of any one of aspects 21-24, wherein the actuation gear further comprises an external gear in driving engagement with the actuation gear, the external gear comprising external gear interface features circumferentially spaced apart from one another about the axis, the external gear interface features configured to be driven by a second motor or actuator of the reusable module.
25. The drug delivery device of aspect 24, wherein the external gear has a ring-shaped body, the external gear interface features are disposed along a circumferential surface of the ring-shaped body, and the external gear includes gear drive teeth formed radially along an axial edge of the ring-shaped body for radial engagement with the actuation gear.
26. The drug delivery device according to any one of aspects 21 to 25, wherein the actuation gear has an axis of rotation perpendicular to the axis.

Claims (7)

1. A drug delivery device comprising a cassette for coupling to a reusable module, said cassette comprising:
a cartridge configured to hold a quantity of medicament, the cartridge extending along a centrally located axis between a proximal end and a distal end;
a stopper drive system configured to drive the medication from the cartridge, the stopper drive system comprising a stopper and an interface end coupled to the stopper and configured to be driven by a first motor or actuator of the reusable module to move the stopper;
a needle assembly directly coupled to the cartridge and movable between a first retracted configuration prior to drug delivery, a second extended configuration during drug delivery , and a third retracted configuration after drug delivery , the needle assembly having an actuation gear movable between a first position and a second position, the actuation gear configured to be driven directly or indirectly by a second motor or actuator of the reusable module, wherein in the second extended configuration, the actuation gear is in the second position and the needle assembly provides fluid communication between the cartridge and the needle assembly, and in the third retracted configuration, the actuation gear is in the first position and no fluid communication is provided between the cartridge and the needle assembly,
the interface end extends from a top end of the cartridge and is coaxial with the shaft, and the actuation gear is positioned to be externally engaged by the second motor or actuator of the reusable module at a location offset from the shaft;
The needle assembly includes a first needle and a second needle;
A drug delivery device , wherein the first needle and the second needle move in opposite directions relative to each other when moving between the first retracted configuration, the second extended configuration, and the third retracted configuration . The drug delivery device of claim 1, wherein the actuation gear further comprises an external gear in driving engagement with the actuation gear, the external gear including external gear interface features spaced circumferentially from one another about the axis, the external gear interface features of the external gear being configured to be driven by the second motor or actuator of the reusable module. The drug delivery device of claim 2, wherein the external gear has a ring-shaped body, the external gear interface features are disposed along a circumferential surface of the ring-shaped body, and the external gear includes gear drive teeth formed along an axial edge of the ring-shaped body for axial engagement with the actuation gear. The drug delivery device of claim 1, wherein the actuation gear further includes an external gear in driving engagement with the actuation gear, the external gear including external gear interface features spaced circumferentially from one another about the axis along a radially inwardly facing surface, the external gear interface features of the external gear configured to be driven by the second motor or actuator of the reusable module. The drug delivery device of claim 4, wherein the external gear has a ring-shaped body, the external gear interface features are disposed along a circumferential surface of the ring-shaped body, and the external gear includes gear drive teeth formed radially along an axial edge of the ring-shaped body for radial engagement with the actuation gear. The drug delivery device of claim 1, wherein the actuation gear has an axis of rotation perpendicular to the axis. The drug delivery device of claim 1, wherein the cartridge includes a fluid housing containing the medication.

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